Investigating urinary microbiome differences in bladder cancer and healthy men
Urinary Microbiome Differences in Bladder Cancer, Benign Urinary Diseases and Healthy Counterpars Adult Male Population: a Pilot Study
This study looks at the differences in bacteria found in the urine of men with bladder cancer, those with other urinary issues, and healthy men to see if these differences are linked to bladder cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | Male |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06992986 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the differences in the urinary microbiome among adult men diagnosed with bladder cancer, those with benign urinary diseases, and healthy counterparts. It focuses on identifying variations in bacterial diversity and richness, which may indicate a relationship between the microbiome and bladder cancer. The study will analyze bacterial profiles based on tumor stage and assess the presence of specific bacterial genera associated with bladder cancer. By understanding these differences, the research seeks to clarify the role of the urinary microbiome in bladder cancer pathology.
Who should consider this trial
Good fit: Ideal candidates include adult men diagnosed with bladder cancer, men with benign urinary diseases, and healthy men within the specified age range.
Not a fit: Patients with other neoplasias, chronic diseases, or those who have undergone specific treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for bladder cancer based on microbiome profiles.
How similar studies have performed: While there have been studies exploring the urinary microbiome, this specific investigation into bladder cancer and benign urinary diseases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (Bladder Cancer Patients): * Diagnosis of bladder cancer * Negative urine culture * Histological confirmation of urothelial carcinoma * Patients undergoing radical cystectomy Exclusion Criteria: * Presence of other neoplasias * History of previous BCG therapy * Use of indwelling catheter * Active antibiotic treatment with two months prior to participation * History of sexual transmitted diseases * Presence of chronic intestinal inflammation * Previous neoadyuvant therapy Inclusion Criteria Controls No-Pathologic/Healthy): \- Controls will be collected from men within the specified age range. Eligible controls may be drawn from the institution's personnel attending the occupational medicine department or in service in the Institute. Exclusion Criteria: * Diabetes * Chronic Kidney Disease * Cardiac disease * Hepatic disease Inclusion Criteria(Benign Urinary Disease) -To ensure that alterations in the microbiome observed in bladder cancer patients are unique to this condition, an additional group with benign urinary diseases will be included in the analysis. This group will encompass individuals with renal cysts, benign prostatic obstruction, ureteropelvic or ureteral obstruction undergoing surgical therapy. Exclusion Criteria: * NA
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Simone, Doctor — IRCCS National Cancer Institute
- Study coordinator: Giuseppe Simone, Doctor
- Email: giuseppe.simone@ifo.it
- Phone: +39-06-5266.5005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.